Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.

Description:

Prolotherapy, also referred to as regenerative injection therapy, joint sclerotherapy, and proliferation therapy, refers to a procedure performed to strengthen the lax or injured ligaments by injecting proliferating agents/sclerosing solutions directly into torn or stretched ligaments. The mild inflammatory response that is created by the injection promotes growth of new ligament or tendon fibers, resulting in a tightening of the weakened area. It is proposed that additional treatments of prolotherapy, over a period of a few weeks, allow a gradual buildup of tissue to restore the original strength to the area and may relieve pain..

Prolotherapy may involve a single or a series of injections of the proliferating agent, which are often diluted with a local anesthetic. Agents used for prolotherapy include zinc sulfate, psyllium seed oil, combinations of dextrose; glycerin; and phenol or dextrose alone. Polidocanol and sodium morrhuate, vascular sclerosants, have also been used to sclerose areas of high intratendinous blood flow associated with tendinopathies..

Various sclerosing agents are used for injection. These sclerosing agents include Asclera® (polidocanol), Varithena® (an injectable polidocanol foam), Sotradecol® (sodium tetradecyl sulfate), Ethamolin® (ethanolamine oleate), and Scleromate® (sodium morrhuate). These agents are not currently approved as joint and ligamentous sclerosing agents.

Practice Guidelines and Position Statements

American College of Occupational and Environmental Medicine

Guidelines on chronic pain from the American College of Occupational and Environmental Medicine (2008) have concluded that the use of prolotherapy for neuropathic or myofascial pain is not recommended.

Guidelines on low back pain from the American College of Occupational and Environmental Medicine (2007, updated in 2011) have concluded that the use of prolotherapy for acute, subacute, chronic or radicular pain syndromes is not recommended.

American College of Occupational and Environmental Medicine (2011) guidelines on hand, wrist, and forearm disorders were unable to make a recommendation about the use of prolotherapy because of insufficient evidence.

European Commission Research Directorate General (ECRDG)

A 2004 ECRDG Working Group that developed guidelines for the treatment of chronic low back pain concluded that there was strong evidence that prolotherapy is not an effective treatment for nonspecific chronic low back pain. Therefore, the Working Group recommended against use of prolotherapy for this disorder.

Prior Approval:

Not applicable

Policy:

Prolotherapy is considered investigational for all applications, including but not limited to:

Achilles tendinosis

Back pain

Epicondylitis

Iliotibial band syndrome.

Knee ligament instability

Knee osteoarthritis

Myofascial pain

Neuropathic pain

Osteomyelitis pubis

Sacroiliac joint pain

Temporomandibular joint syndrome/Temporomandibular oint hypermobility

Tendinopathies

Groin pain

All lower limb tendinopathies

All musculoskeletal pain

The literature consists of small randomized trials on a variety of pain syndromes with inconsistent results. The body of scientific evidence does not permit conclusions concerning the effect of prolotherapy on health outcomes for chronic neck or back pain, tendinopathies of the upper or lower limbs, osteoarthritic pain, or other musculoskeletal pain conditions. Systematic review of the literature found limited evidence that prolotherapy injections are a safe and effective treatment for Achilles tendinopathy, plantar fasciopathy and Osgood-Schlatter disease. More robust research using large, methodologically-sound randomized controlled trials is required. Therefore, prolotherapy is considered investigational for all indications.

Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc.They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.